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Description

Offer is valid subject to confirmation, country by country. Development of this pharmaceutical is carried out according to EU-requirements in country without patent protection or with Bolar-provisions. There will be no sales in those countries where this offer would constitute an infringement of third parties intellectual proprietary rights.

1. NAME OF THE MEDICINAL PRODUCT

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

3. PHARMACEUTICAL FORM

Film coated tablets.

4. CLINICAL PARTICULARS

4.1 Therapeutic indications

Ofloxacin is a synthetic 4-fluoroquinolone antibacterial agent with bactericidal activity against a wide range of Gram-negative and Gram-positive organisms. It is indicated for the treatment of the following infections when caused by sensitive organisms: Upper and lower urinary tract infections; lower respiratory tract infections; uncomplicated urethral and cervical gonorrhoea; non-gonococcal urethritis and cervicitis, skin and soft tissue infections.

4.2 Posology and method of administration

General dosage recommendations: The dose of ofloxacin is determined by the type and severity of the infection. The dosage range for adults is 200 mg to 800 mg daily. Up to 400mg may be given as a single dose, preferably in the morning. Larger doses should be given as two divided doses. Generally, individual doses are to be given at approximately equal intervals. OXLOXACIN tablets should be swallowed with liquid; they should not be taken within two hours of magnesium/aluminium containing antacids, sucralfate or iron preparations since reduction of absorption of ofloxacin can occur. Lower urinary tract infection: 200-400mg daily. Upper urinary tract infection: 200-400mg daily increasing, if necessary, to 400 mg twice a day. Lower respiratory tract infection: 400 mg daily increasing, if necessary, to 400 mg twice daily. Uncomplicated urethral and cervical gonorrhoea: A single dose of 400 mg. Non-gonococcal urethritis and cervicitis: 400 mg daily in single or divided doses. Skin and soft tissue infections: 400 mg twice daily.Impaired renal function: Following a normal initial dose, dosage should be reduced in patients with impairment of renal function. When creatinine clearance is 20-50 ml/minute (serum creatinine1.5-5.0mg/dl) the dosage should be reduced by half (100-200mg daily). If creatinine clearance is less than 20 ml/minute (serum creatinine greater than 5 mg/dl) 100 mg should be given every 24 hours. In patients undergoing haemodialysis or peritoneal dialysis, 100 mg should be given every 24 hours.Impaired liver function: The excretion of ofloxacin may be reduced in patients with severe hepatic dysfunction.Elderly: No adjustment of dosage is required in the elderly, other than that imposed by consideration of renal or hepatic function.Children: Ofloxacin is not indicated for use in children or growing adolescents.Duration of treatment: Duration of treatment is dependent on the severity of the infection and the response to treatment. The usual treatment period is 5-10 days except in uncomplicated gonorrhoea, where a single dose is recommended. Treatment should not exceed 2 months duration.

4.3 Contraindications

Ofloxacin should not be used in patients with known hypersensitivity to 4-quinolone antibacterials, or any of the tablet excipients. Ofloxacin should not be used in patients with a past history of tendinitis. Ofloxacin, like other 4-quinolones, is contra-indicated in patients with a history of epilepsy or with a lowered seizure threshold. Ofloxacin is contra-indicated in children or growing adolescents, and in pregnant or breast-feeding women, since animal experiments do not entirely exclude the risk of damage to the cartilage of joints in the growing subject. Patients with latent or actual defects in glucose-6-phosphate dehydrogenase activity may be prone to haemolytic reactions when treated with quinolone antibacterial agents.

4.4 Special warnings and special precautions for use

Patients being treated with ofloxacin should not expose themselves unnecessarily to strong sunlight and should avoid UV rays (sunlamps, solaria). Caution is recommended if the drug is to be used in psychotic patients or in patients with a history of psychiatric disease. Administration of antibiotics, especially if prolonged, may lead to proliferation of resistant micro-organisms. The patient's condition must therefore be checked at regular intervals. If a secondary infection occurs, appropriate measures must be taken.

4.5 Interaction with other medicinal products and other forms of Interaction

Co-administered magnesium/aluminium antacids, sucralfate or iron preparations can reduce absorption. Therefore, ofloxacin should be taken 2 hours before such preparations. Prolongation of bleeding time has been reported during concomitant administration of OXLOXACIN and anticoagulants. There may be a further lowering of the cerebral seizure threshold when quinolones are given concurrently with other drugs which lower the seizure threshold e.g. theophylline. However, ofloxacin is not thought to cause a pharmacokinetic interaction with theophylline, unlike some other fluoroquinolones. Further lowering of the cerebral seizure threshold may also occur with certain nonsteroidal anti-inflammatory drugs. Ofloxacin may cause a slight increase in serum concentrations of glibenclamide administered concurrently; patients treated with this combination should be closely monitored. With high doses of quinolones, impairment of excretion and an increase in serum levels may occur when co-administered with other drugs that undergo renal tubular secretion (e.g. probenecid, cimetidine, frusemide and methotrexate).Interactions with laboratory tests: Determination of opiates or porphyrins in urine may give false-positive results during treatment with ofloxacin.

4.6 Pregnancy and lactation

The safety of this medicinal product for use in human pregnancy has not been established. Reproduction studies performed in rats and rabbits did not reveal any evidence of teratogenicity, impairment of fertility or impairment of peri- and post-natal development. However, as with other quinolones, ofloxacin has been shown to cause arthropathy in immature animals and therefore its use during pregnancy is not recommended. Studies in rats have indicated that ofloxacin is secreted in milk. It should therefore not be used during lactation.

4.7 Effects on ability to drive and use machines

Since there have been occasional reports of somnolence, impairment of skills, dizziness and visual disturbances, patients should know how they react to OXLOXACIN before they drive or operate machinery. These effects may be enhanced by alcohol.

4.8 Undesirable effects

The overall frequency of adverse reactions from the clinical trial data base is about 7%. The commonest events involved the gastrointestinal system (about 5.0%) and the nervous system (about 2.0%). The following provides a tabulation based on post marketing experience where occasional represents a frequency of 0.1-1.0%, rare <0.1%, very rare 0.01% and isolated cases 0.01%.Digestive and liver side effects: Occasional: Nausea and vomiting, diarrhoea, abdominal pain, gastric symptoms. (Diarrhoea may sometimes be a symptom of enterocolitis which may, in some cases, be haemorrhagic). Rare: Loss of appetite, increase in liver enzymes and/or bilirubin. Very rare: cholestatic jaundice, hepatitis or severe liver damage may develop. A particular form of enterocolitis that can occur with antibiotics is pseudomembranous colitis (in most cases due to Clostridium difficile). Even if Clostridium difficile is only suspected, administration of ofloxacin should be discontinued immediately, and appropriate treatment given. Drugs that inhibit peristalsis should not be administered in such cases.Central nervous system: Occasional: Headache, dizziness, sleep disorders, restlessness. Rare: Confusion, nightmares, anxiety, depression, hallucinations and psychotic reactions, drowsiness, unsteady gait and tremor (due to disorders of muscular co-ordination), neuropathy, numbness and paraesthesia or hypaesthesiae, visual disturbances, disturbances of taste and smell (including, in exceptional cases, loss of function), extrapyramidal symptoms. Very rare: Convulsions, hearing disorders (including, in exceptional cases, loss of hearing). These reactions have occurred in some patients after the first dose of ofloxacin. In such cases, discontinue treatment immediately.Cardiovascular system: Tachycardia and a temporary decrease in blood pressure have been reported. Rare: circulatory collapse (due to pronounced drop in blood pressure).Haematological side effects: Very rare: anaemia, leucopenia (including agranulocytosis), thrombocytopenia, pancytopenia. Only in some cases are these due to bone marrow depression. In very rare cases, haemolytic anaemia may develop.Renal side effects: Rare: Disturbances of kidney function. Isolated cases: Acute interstitial nephritis, or an increase in serum creatinine, which may progress to acute renal failure.Allergic and skin side effects: Occasional: Skin rash, itching. Very rare: Rash on exposure to strong sunlight, other severe skin reactions. Hypersensitivity reactions, immediate or delayed, usually involving the skin (e.g. erythema multiforme, Stevens-Johnson syndrome, Lyell's syndrome and vasculitis) may occur. In exceptional circumstances, vasculitis can lead to skin lesions including necrosis and may also involve internal organs. There are rarely other signs of anaphylaxis such as tachycardia, fever, dyspnoea, shock, angioneurotic oedema, vasculitic reactions, eosinophilia. In these cases treatment should be discontinued immediately and where appropriate, supportive treatment given. Isolated cases: Pneumonitis.Other side effects: Rare: Malaise. Very rare: Excessive rise or fall in blood-sugar levels. Weakness, joint and muscle pains (in isolated cases these may be symptoms of rhabdomyolysis). Isolated cases: Tendon discomfort, including inflammation and rupture of tendons (e.g. the Achilles tendon) particularly in patients treated concurrently with corticosteroids. In the event of signs of inflammation of a tendon, treatment with OXLOXACIN must be halted immediately and appropriate treatment must be initiated for the affected tendon. The possibility cannot be ruled out that ofloxacin may trigger an attack of porphyria in predisposed patients. Except in very rare instances (e.g. isolated cases of smell, taste and hearing disorders) the adverse effects observed subsided after discontinuation of ofloxacin.

4.9 Overdose

The most important signs to be expected following acute overdosage are CNS symptoms such as confusion, dizziness, impairment of consciousness and convulsive seizures, as well as gastrointestinal reactions such as nausea and mucosal erosions. In the case of overdose steps to remove any unabsorbed ofloxacin e.g. gastric lavage, administration of adsorbants and sodium sulphate, if possible during the first 30 minutes, are recommended; antacids are recommended for protection of the gastric mucosa. Elimination of ofloxacin may be increased by forced diuresis.

5.2 Pharmacokinetic properties

Ofloxacin is almost completely absorbed after oral administration. Maximal blood levels occur 1-3 hours after dosing and the elimination half-life is 4-6 hours. Ofloxacin is primarily excreted unchanged in the urine. In renal insufficiency the dose should be reduced. No clinically relevant interactions were seen with food and no interaction was found between ofloxacin and theophylline.

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